Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion (WIND)

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00869063
First received: March 24, 2009
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

The purpose of the study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain, strain or contusion when applied to the painful area.


Condition Intervention Phase
Acute Pain
Drug: Diclofenac Sodium Patch
Drug: Matching Placebo Patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion

Resource links provided by NLM:


Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Change in average pain during daily activity [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in average pain during daily activity [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Sodium Patch Drug: Diclofenac Sodium Patch
Topical 1% diclofenac sodium patch, applied once daily for 7 days
Placebo Comparator: Placebo Patch Drug: Matching Placebo Patch
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days

Detailed Description:

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 17 - 75 years of age
  • Sustained recent, painful unilateral mild to moderate wrist sprain, strain or contusion
  • Meet baseline pain criterion

Exclusion Criteria:

  • Open wound or infection at the site of injury
  • Severe wrist injury or wrist fracture
  • Presence or history of hand, wrist or forearm nerve impingement or palsies
  • Use of NSAIDs or opioids within 12 - 24 hours of wrist injury
  • Presence or history of peptic ulcers or GI bleeding
  • History of intolerance to NSAIDs, acetaminophen, adhesives
  • Positive pregnancy test
  • Positive drug screen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869063

Locations
United States, Texas
PPD
Austin, Texas, United States, 78704
Sponsors and Collaborators
Cerimon Pharmaceuticals
PPD
  More Information

No publications provided

Responsible Party: Shaily J. Reichert, V.P. of Clinical Development, Cerimon Pharmaceuticals, inc.
ClinicalTrials.gov Identifier: NCT00869063     History of Changes
Other Study ID Numbers: DCF-005
Study First Received: March 24, 2009
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerimon Pharmaceuticals:
wrist
sprain
strain
contusion
diclofenac
patch
acute pain
acute pain due to mild to moderate wrist sprain, strain or contusion

Additional relevant MeSH terms:
Acute Pain
Contusions
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Wounds and Injuries
Wounds, Nonpenetrating
Diclofenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014